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Completed

NCT Number: NCT01581840

Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.

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Key information

Conditions

Epidermoid Carcinoma Anus Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pessac - Hôpital Haut Lévêque, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven epidermoid carcinoma of the anus
  • Locally advanced tumour without metastases
  • Stage T2>3 cm or T3 or T4, irrespective of N
  • Stage N1-N3 irrespective of T stage (T1 to T4)
  • General condition WHO 0-1
  • Life expectancy > 3 months
  • Signed informed consent form
  • Age > 18 years
  • Effective contraception in female and/or male patients having reached sexual maturity during treatment and up to 6 months after the end of treatment
  • CD4 > 400 / mm3
  • Measureable tumor on at least one of the following exams : MRI, endoscopic ultrasonography, clinical exam

Exclusion criteria

  • Presence of metastases
  • Previous anti-EGFR therapy
  • Stage T1N0 or T2 < 3 cm N0
  • History of pelvic radiotherapy
  • At least one of the following laboratory test results: Neutrophils < 1500 /mm3, platelets < 100 000 /mm3, Hb < 9 g/dl, leukocytes < 3000/mm3, blood bilirubin > 1.5 times the upper limit of the normal range, transaminase (ASAT and ALAT) > 2.5 times the upper limit of the normal range, creatinine clearance < 50 mL/min (Cockcroft's formula Appendix x), Mg2+ < the lower limit of the normal range, Ca2+ < the lower limit of the normal range
  • Significant coronary artery disease or myocardial infarction in the past year
  • Follow-up not possible due to psychological or geographic reasons
  • History of interstitial pneumonitis or pulmonary fibrosis
  • History of malignant disease in the past five years apart from basocellular skin carcinoma or in situ cervical carcinoma having received adequate treatment
  • Pregnant or breast-feeding women, women of child-bearing potential not having taken a pregnancy test.

Treatment and study plan

Radiochemotherapy

Drug

Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²

Panitumumab

Drug

3 or 6 mg/kg (according to dose level)

Primary outcomes

  1. Percentage of Patients With Complete Response to Treatment

    Time frame: 8 weeks evaluations after the end of the treatment by radiochemotherapy

    Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance. The responses were validated by an independent committee:

    • In the event of a discrepancy between the investigator and the independent committee, the independent committee's response was used;
    • in case of uncertainty of the investigator on the response, the committee decided on the response in view of the clinical and morphological data; This endpoint was assessed 8 weeks after the end of treatment (week 15). A patient who died (regardless of cause) was considered a failure for the primary endpoint

Secondary outcomes

  1. Percentage of Patients With Complete Response to Treatment

    Time frame: 16 weeks after the end of the treatement by radiotherapy

    Complete response was defined by the complete disappearance of the tumor on proctological examination and morphological examinations (MRI and/or echo-endoscopy) and the absence of secondary lesion appearance according to the investigator's opinion

  2. 3 Years Colostomy-free Survival (CFS)

    Time frame: At 3 years after inclusion

    It was defined as the time from inclusion to the date of colostomy or death (from any cause). Patients alive without colostomy were censored at date of last news. If a patient had a shunt colostomy and continuity wasrestored, the patient was counted among the patients without a colostomy.

  3. Recurrence-free Survival (RFS) at 3 Years

    Time frame: At 3 years after inclusion

    It was defined as the time from inclusion to the date of first recurrence (local, regional, metastatic and second anal cancer) or death. Patients alive without recurrence were censored at date of last news.

  4. Overall Survival (OS) at 12 Months

    Time frame: At 12 months after inclusion

    The percentage was evaluated at 12 months using the Kaplan Meier estimation.

    In the safety part all the death collected during the study will be reported.

Sponsors and collaborators

Lead sponsor

Federation Francophone de Cancerologie Digestive

Other

Registry information

Official study title

Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Apr 20, 2012
Registry last updated
Jul 1, 2024

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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