Evidence map›Paper›PMID 37156624›Full record

ArticleCancer medicine2023

Total neoadjuvant treatment to increase the clinical complete response rate for distal locally advanced rectal cancer (TESS): A study protocol of a prospective, open-label, multicenter, single-arm, phase 2 trial.

Shuang Liu, XiaoZhong Wang, YeZhong Zhuang, ShouMin Bai, XiaoJun Wu, YiJing Ye, HuiLong Luo, HaiNa Yu, QiaoXuan Wang, Hui Chang and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Shuang LiuDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
XiaoZhong WangDepartment of General Surgery, Shantou Central Hospital, Shantou, China.
YeZhong ZhuangDepartment of Abdominal Surgery, Cancer Hospital of Shantou University Medical College, Shantou, China.
ShouMin BaiDepartment of Radiation Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
XiaoJun WuSun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
YiJing YeDepartment of Radiation Oncology, Zhongshan People's Hospital, Zhongshan, China.
HuiLong LuoDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
HaiNa YuDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
QiaoXuan WangDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Hui ChangDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0001-6651-5101
ZhiFan ZengDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
PeiQiang CaiSun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
ZhiZhong PanSun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
YuanHong GaoDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0002-6429-5376
Gong ChenSun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
WeiWei XiaoDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0002-9922-640X
Sun Yat-sen University · CNShantou Central Hospital · CNShantou University · CNZhongshan People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStandard treatment of locally advanced rectal cancer (LARC) was neoadjuvant chemoradiotherapy (CRT), followed by total mesorectal excision (TME). Total neoadjuvant treatment (TNT), a new concept, attempts to deliver both systemic chemotherapy and neoadjuvant CRT prior to surgery. Patients treated with neoadjuvant chemotherapy were more likely to show higher tumor regression. The objective of this trial was to increase complete clinical rate (cCR) for LARC patients by optimizing tumor response, using TNT regimen as compared to conventional chemoradiotherapy. TESS, a prospective, open-label, multicenter, single-arm, phase 2 study, is underway.

methodsMain inclusion criteria include cT3-4aNany or cT1-4aN+ rectal adenocarcinoma aged 18-70y; Eastern Cooperative Oncology Group (ECOG) performance 0-1; location ≤5 cm from anal verge. Ninety-eight patients will receive 2 cycles of neoadjuvant chemotherapy Capeox (capecitabine + oxaliplatin) before, during, and after radiotherapy 50Gy/25 fractions, before TME (or other treatment decisions, such as Watch and Wait strategy) and adjuvant chemotherapy capecitabine 2 cycles. Primary endpoint is the cCR rate. Secondary endpoints include ratio of sphincter preservation strategy; pathological complete response rate and tumor regression grade distribution; local recurrence or metastasis; disease-free survival; locoregional recurrence-free survival; acute toxicity; surgical complications; long-term anal function; late toxicity; adverse effect, ECOG standard score, and quality of life. Adverse events are graded per Common Terminology Criteria for Adverse Events V5.0. Acute toxicity will be monitored during antitumor treatment, and late toxicity will be monitored for 3 years from the end of the first course of antitumor treatment. DISCUSSION: The TESS trial aims to explore a new TNT strategy, which is expected to increase the rate of cCR and sphincter preservation rate. This study will provide new options and evidence for a new sandwich TNT strategy in patients with distal LARC.

Indexed as

Neoplasms, Second PrimaryRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineChemoradiotherapyClinical Trials, Phase II as TopicFluorouracilHumansMulticenter Studies as TopicNeoadjuvant TherapyNeoplasm StagingOxaliplatinProspective StudiesQuality of LifeTreatment OutcomeCapecitabineFluorouracilOxaliplatinclinical trialsneoadjuvant chemotherapyrectal cancersurgical oncology

Identifiers

PMID37156624
PMCPMC10315856
OpenAlexW4375955185

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.