Anal CancerPhase 3NCT00003652
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
A Phase 3 study testing cisplatin, fluorouracil and neoadjuvant therapy in people with Anal Cancer, run by UNICANCER at 48 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Anal Cancer
- What is being tested?
- cisplatin, fluorouracil and neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 48 sitesFrance
- Study dates
- 4 Jan 1999to 31 Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven nonmetastatic anal cancer
- Anal/rectal junction OR
- Anal/cutaneous junction with the majority of the tumor in the anal canal, above the junction
- Epidermoid cancer (well-differentiated, fairly differentiated, or basaloid) OR
- Cloacogenic cancer
- Stage II or III
- T2 at least 4 cm OR
- T3 OR
- T4, N0-3, M0 OR
- T1, N1-3 OR
- T2 (less than 4 cm), N1-3
- Tumors at least 4 cm in greatest dimension and/or tumors with lymph node invasion must be nonmetastatic by ultrasound
- No prior surgery to remove tumor
PATIENT CHARACTERISTICS:
Age:
- 80 and under
Performance status:
- WHO 0 or 1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 11 g/dL (transfusion allowed)
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No cardiac condition contraindicating use of fluorouracil
Other:
- No prior malignancy within 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or breast
- No other serious medical or psychological condition
- No serious immunosuppression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior endocrine therapy
Radiotherapy:
- No prior pelvic or inguinal radiotherapy
Surgery:
- See Disease Characteristics
- No prior definitive colostomy
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
France48 sites
Centre Paul Papin
Angers, 49036
Institut Sainte Catherine
Avignon, 84082
Institut Bergonie
Bordeaux, 33076
CHU Ambroise Pare
Boulogne-Billancourt, F-92104
C.H. Bourg En Bresse
Bourg-en-Bresse, 01012
Centre Regional Francois Baclesse
Caen, 14076
Centre Hospitalier
Chalon-sur-Saône, F-71321
Hopital Louis Pasteur
Colmar, 68024
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
Centre Hospitalier Departemental
La Roche-sur-Yon, F-85025
Centre Oscar Lambret
Lille, 59020
Centre Hospital Regional Universitaire de Limoges
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Institut J. Paoli and I. Calmettes
Marseille, 13273
CHU de la Timone
Marseille, 13385
Hopital Clinique Claude Bernard
Metz, 57072
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Hospitalier de Mulhouse
Mulhouse, 68051
Centre D'Oncologie De Gentilly
Nancy, 54100
Centre Catherine de Sienne
Nantes, 02
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805
Centre Antoine Lacassagne
Nice, 06189
CHR D'Orleans - Hopital de la Source
Orléans, 45067
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Bichat - Claude Bernard
Paris, 75018
Hopital Robert Debre
Paris, 75019
Institut Curie - Section Medicale
Paris, 75248
Hopital Saint-Louis
Paris, 75475
CHU Pitie-Salpetriere
Paris, 75651
Hopital Tenon
Paris, 75970
Hopital Jean Bernard
Poitiers, 86021
Clinique Ste - Marie
Pontoise, 95301
Institut Jean Godinot
Reims, 51056
Centre Eugene Marquis
Rennes, 35042
Hopital Charles Nicolle
Rouen, 76031
Centre Henri Becquerel
Rouen, 76038
Clinique Armoricaine De Radiologie
Saint-Brieuc, F-22015
Centre Rene Huguenin
Saint-Cloud, 92211
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, 44600
Clinique de l'Orangerie
Strasbourg, 67010
Centre Paul Strauss
Strasbourg, 67065
Centre Hospitalier Regional Metz Thionville
Thionville, 57126
Institut Claudius Regaud
Toulouse, 31052
Clinique Fleming
Tours, 37000
Nouvelle Clinique Generale
Valence, 26000
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of concurrent chemotherapy and radiotherapy with or without neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or III anal canal cancer.
- Compare the efficacy of two levels of radiation dose in patients with stage II or III anal canal cancer.
- Compare the sphincter conservation of the anus by these regimens.
- Compare the effect of these regimens on survival and quality of life of these patients.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to one of four treatment arms.
- Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2 courses. Beginning 4 weeks later, patients receive chemoradiotherapy. This regimen consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 and repeated 4 weeks later, plus pelvic radiotherapy beginning on day 1 and continuing for 5 weeks (once a day, 5 days/week). Patients receive low dose radiotherapy directly to the tumor beginning 3 weeks later and continuing for 2 weeks.
- Arm II: Patients receive induction chemotherapy and chemoradiotherapy as in arm I, plus high dose radiotherapy directly to the tumor.
- Arm III (control arm): Patients receive chemoradiotherapy and low dose radiotherapy to the tumor as in arm I.
- Arm IV: Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in arm II.
After study treatment is completed, patients with nonfixed inguinal tumors may undergo surgical resection followed by radiotherapy or radiotherapy alone. Patients with fixed inguinal tumors may receive further radiotherapy alone.
Quality of life is assessed before treatment, at 2 months after completion of treatment, and at 5 years.
Patients are followed every 4 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
- Conditions
- Anal Cancer
- Being tested
- cisplatin, fluorouracil, neoadjuvant therapy, radiation therapy
- Keywords
- stage II anal cancer, stage III anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus
- Medical subject headings
- Anus Neoplasms, Anal Canal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
neoadjuvant therapyProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start4 Jan 1999
- Primary completion1 Apr 2006
- Study completion31 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Peiffert, MD, Study chair, Centre Alexis Vautrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003652
- Sponsor's protocol ID
- CDR0000066744
- Other IDs
- FNCLCC-FFCD-SFRO-ACCORD-3, EU-98050
- Status last verified
- Feb 2021
- First submitted
- 1 Nov 1999
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.
PubMed 18191265
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study
- ClinicalTrials.gov ID
- NCT00003652
- Acronym / sponsor ID
- CDR0000066744
- Conditions
- Anal Cancer
- Keywords
- stage II anal cancer, stage III anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 4 Jan 1999 (actual)
- Primary completion
- 1 Apr 2006 (actual)
- Study completion
- 31 Mar 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.
Detailed description
OBJECTIVES:
- Compare the efficacy of concurrent chemotherapy and radiotherapy with or without neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or III anal canal cancer.
- Compare the efficacy of two levels of radiation dose in patients with stage II or III anal canal cancer.
- Compare the sphincter conservation of the anus by these regimens.
- Compare the effect of these regimens on survival and quality of life of these patients.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to one of four treatment arms.
- Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2 courses. Beginning 4 weeks later, patients receive chemoradiotherapy. This regimen consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 and repeated 4 weeks later, plus pelvic radiotherapy beginning on day 1 and continuing for 5 weeks (once a day, 5 days/week). Patients receive low dose radiotherapy directly to the tumor beginning 3 weeks later and continuing for 2 weeks.
- Arm II: Patients receive induction chemotherapy and chemoradiotherapy as in arm I, plus high dose radiotherapy directly to the tumor.
- Arm III (control arm): Patients receive chemoradiotherapy and low dose radiotherapy to the tumor as in arm I.
- Arm IV: Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in arm II.
After study treatment is completed, patients with nonfixed inguinal tumors may undergo surgical resection followed by radiotherapy or radiotherapy alone. Patients with fixed inguinal tumors may receive further radiotherapy alone.
Quality of life is assessed before treatment, at 2 months after completion of treatment, and at 5 years.
Patients are followed every 4 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
| neoadjuvant therapy | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Results publication: PubMed 18191265Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Peiffert, MD study chair
Centre Alexis Vautrin
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, fluorouracil and neoadjuvant therapy in people with Anal Cancer, run by UNICANCER at 48 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.