Evidence map›Paper›PMID 35142654›Full record

ArticleThe Indian journal of medical research2021

Temporal course of late rectal toxicity & impact of intervention in patients undergoing radiation for cervical cancer.

Jagadish Shejul, Supriya Chopra, Nilesh Ranjan, Umesh Mahantshetty, Shaesta Mehta, Prachi Patil, Reena Engineer, Lavanya Gurram, Reena Phurailatpam, Jamema Swamidas and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in The Indian journal of medical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07164534 (A Phase III Trial to Assess the Effectiveness of NRF2 Activator), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT07164534 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase III Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity. (CHOC-LATE Trial)

TypeinterventionalSponsorTata Memorial HospitalRan2026 to 2030Enrolled316ConditionsUterine Cervical NeoplasmArmsSodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts.
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Jagadish ShejulDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Supriya ChopraDepartment of Advanced Centre for Treatment, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Nilesh RanjanDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Umesh MahantshettyDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Shaesta MehtaDepartment of Digestive Diseases & Clinical Nutrition, Tata Memorial Centre, Tata Memorial Hospital, Homi Bhabha National Institute, Navi Mumbai, Maharashtra, India.
Prachi PatilDepartment of Digestive Diseases & Clinical Nutrition, Tata Memorial Centre, Tata Memorial Hospital, Homi Bhabha National Institute, Navi Mumbai, Maharashtra, India.
Reena EngineerDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Lavanya GurramDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Reena PhurailatpamDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Jamema SwamidasDepartment of Radiation Oncology, Research & Education in Cancer, Navi Mumbai, Maharashtra, India.
Sudeep GuptaDepartment of Medical Oncology, Tata Memorial Centre, Tata Memorial Hospital, Homi Bhabha National Institute, Navi Mumbai, Maharashtra, India.
Shyam ShrivastavaDepartment of Radiation Oncology, Apollo Hospital, Navi Mumbai, Maharashtra, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

objectives: There is limited information available on the temporal course of late stage radiotherapy adverse effects. The present study reports on the temporal course of late toxicities after chemoradiation and brachytherapy.

methods: Women with cervical cancer who presented with late toxicity after (chemo) radiation were included in the study. Grade of toxicity (Clinical Toxicity Criteria for Adverse Events version 4.03) and type of intervention were recorded at three-monthly interval for the first year and then six monthly until 24 months. Direct cost for the management of toxicity was calculated. Univariate analysis was performed to understand the impact of various factors on persistence of toxicity.

results: Ninety two patients were included in this study. Grades I, II, III and IV toxicities were observed in 50 (54%), 33 (36%), 7 (8%) and 2 (2%) patients, respectively, at first reporting. Patients spent a median of 12 (3-27) months with toxicity. At 12 months, 48/92 (52.2%) patients had a complete resolution of toxicity, whereas 27/92 (29.3%) patients had low grade (I-II) persistent toxicity. Only 6/92 (6.5%) patients who had grade III-IV toxicity had resolution to a lower grade. Four (4.3%) patients died due to toxicity. At 24 months, 9 (10%) patients continued to have grade ≥ III toxicity. On an average, 7 (2-24) interventions were required for the clinical management of late toxicity and median direct cost incurred was ₹ 50,625 (1,125-303,750). INTERPRETATION &

conclusions: In this study late radiation toxicity resolved within 12 months in more than half of patients. However, others are likely to have had persistent lower grade toxicity or progression to higher grade. Structured strategies are hence needed for the effective management of late toxicities.

Indexed as

AdenocarcinomaBrachytherapyRadiation InjuriesUterine Cervical NeoplasmsChemoradiotherapyFemaleHumansCervical cancerlate rectal toxicityproctitisradiotherapyrectal ulcertemporal course

Identifiers

PMID35142654
PMCPMC9131765

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Registered trials

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.