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Completed

NCT Number: NCT03200249

Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers

Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis

Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy
  • Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
  • Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy
  • Operable Patient
  • Age between 18 and 75
  • OMS performance status 0-2
  • No co-morbidity likely to prevent the delivery of treatment
  • Adequate contraception for men, and for non-menopausal women
  • Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL
  • Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS
  • Creatinine clearance> 50 mL / min
  • Patient must have been informed and must have signed the specific informed consent form.
  • Patient must be affiliated to a Social Health Insurance.

Exclusion criteria

  • Remote metastasis
  • Cancer not resectable
  • Contraindication to capecitabine and its excipients
  • Previous history of pelvic radiotherapy or previous chemotherapy
  • History of inflammatory bowel or rectum disease
  • History of angina pectoris monitored or myocardial infarction or heart failure
  • Active active infection or other serious underlying condition that may prevent the patient from receiving treatment
  • Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma
  • Patient already included in another therapeutic trial with an experimental molecule
  • Pregnant woman, likely to be pregnant or nursing
  • Persons deprived of their liberty or under guardianship
  • Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

Treatment and study plan

Preoperative chemo-radiation with IG-IMRT dose escalation

Radiation

Primary outcomes

  1. Complete histological response rate

    Time frame: at 8 weeks after inclusion

    Absence of residual cancer cells on the final analysis of the tumor and lymph node

Secondary outcomes

  1. Tolerance

    Time frame: at 1, 2, 3, 4, 5 and 13 weeks after inclusion and at 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after surgery

    Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)

Acronym: RADICAL

Important dates

Study start
2016
Primary completion
2016
Study completion
2020
First posted
Jun 27, 2017
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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